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9/21/2001

Bayer Recalls Unrefrigerated Lots of Helixate FS, Kogenate FS

Cheryl A. Thompson

Unrefrigerated lots of Helixate FS and Kogenate FS are being recalled by Bayer Corp. because they may have less than 80 percent of their labeled potency after nine weeks.

The company is recalling Helixate FS vials in lots 372J001C and 372J023A and Kogenate FS vials in lot 372J009A only if they have not been stored continuously in the refrigerator. Bayer manufactures both recombinant antihemophilic factor products and distributes Kogenate FS; Aventis Behring distributes Helixate FS. The companies had announced in late July that the labeling for the products would no longer include the option of storing the vials at room temperature for up to two months.

Bayer initiated the recall on Sept. 12. The original announcement from the Food and Drug Administration, dated Sept. 14, mentioned only the two lots of Helixate FS. Today's follow-up announcement added the Kogenate FS lot, which was distributed in Canada.